MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 16CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 16CT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Hello, my boyfriend has recently bought a dental guard and it is one of the small soft dental guards.While waking up this morning he seemed to not be able to find, we flipped the room upside down just looking for it.We both believe that he has swallowed the grind no more, and while he is in no pain i just wanted to know what would be the best option.

• Brand Name: PLACKERS MTH GD GNM 16CT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave, se; grand rapids MI 49512 5353
• MDR Report Key: 12418211
• MDR Text Key: 271096340
• Report Number: 1825660-2021-00999
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 5108065152
• UDI-Public: 5108065152
• Combination Product (y/n): N
• PMA/PMN Number: K094020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 16CT
• Device Lot Number: 112819
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2021
• Date Manufacturer Received: 08/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1